Currently three main pillars of medicine exist- biologics, medical devices, and pharmaceuticals. While the FDA is still in the process of building a foundation of the cell therapy industry, there exists a need for this type of medical development to meet the needs of patients. Before any of these life-saving innovations can reach the public, they must meet the requirements for being proven safe and effective in clinical research- and have success in clinical trials.

Inappropriate patient populationSome may want to treat all patients with same disease in order to target broader market. But in reality, only some subsets of patients will benefit meaning a targeted patient population is important.

Control groups issuesBy definition, control groups are the standard by which observations are evaluated.Trials should be appropriately controlled, started from Phase 2. If control groups are added in late-stage of a trial they could abolish the efficacy.

Discontinuity between research and commercial processMany great research findings simply will not translate when the manufacturing process is optimized.

Bad trial managementThis may include many variables, such as lack of enrollment, lack of clinical operations experience, poor data management, and biases.

Check out the blog by Alexey Bersenev, which provides a lot of great information for current trends in cell therapy. What are your thoughts on this emerging pillar in medicine? Share your thoughts below!